CSV Engineer

2 weeks ago

Navi Mumbai, Maharashtra, India The closing Gap Full time ₹ 2,88,000 - ₹ 3,24,000 per year

Job Title: CSV Engineer (Computer System Validation)

Experience: 0–1 year

Location: Mahape, Navi Mumbai

Monthly CTC: ₹27,000

Joining Preference: 0–15 days

About the Role

We are looking for an enthusiastic CSV Engineer to join our IT & Clinical Systems team. The role involves software testing, validation, documentation, and support for Clinical Trial Management Systems (CTMS) and related applications. This is an excellent opportunity for freshers or early-career professionals to build expertise in clinical domain IT systems.

Key Responsibilities

  • Perform software testing and validation activities.
  • Prepare, execute, and review CSV-related documents (URS, FRS, SOPs).
  • Conduct IQ/OQ/PQ for CTMS systems and validate new deployments.
  • Design eCRFs, user requirements, edit rules/checks, and data validations.
  • Create, update, validate, and maintain project documentation.
  • Monitor, resolve, and track queries in study data.
  • Ensure clinical data within EDC is compliant for lock/unlock and freeze/unfreeze activities.
  • Manage CDM (Clinical Data Management) activities with trial monitors.
  • Participate in data reviews, presentations, and vendor meetings.
  • Handle instrument interfacing and procurement master creation as per software needs.
  • Mentor or train team members where required.
  • Collaborate with cross-functional teams, stakeholders, and vendors to ensure smooth operations.
  • Ensure compliance with healthcare industry standards and regulatory requirements.
  • Support any additional assignments allocated by Section Head/Head Operations IT.

Skills & Qualifications

  • 0–1 year of relevant experience in CSV / CTMS / IT Validation / Software Testing.
  • Strong understanding of clinical data systems, documentation, and compliance.
  • Knowledge of IQ/OQ/PQ, EDC, data reconciliation, and validation processes.
  • Good communication and collaboration skills to work with cross-functional teams.
  • Ability to quickly learn and adapt to new technologies and regulatory requirements.

Job Type: Full-time

Pay: ₹24, ₹27,000.00 per month

Work Location: In person

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